Phase 2 study of Magrolimab Combination Therapy in Metastatic TNBC
Research type
Research Study
Full title
A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy and of Magrolimab in Combination with Nab-Paclitaxel or Paclitaxel versus Nab-Paclitaxel or Paclitaxel in Previously Untreated Patients with Metastatic Triple-Negative Breast Cancer
IRAS ID
305446
Contact name
Anne Armstrong
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2021-001074-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 4 days
Research summary
Research summary:
Triple negative breast cancer (TNBC) accounts for 15-20% of breast cancer. It is typically more aggressive, with a faster proliferation rate, than other types of breast cancer. TNBC cells do not have the receptors commonly found in other breast cancers; oestrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2. This means treatment with hormonal or targeted therapy will not be effective. The treatment options for TNBC include chemotherapy, surgery, and radiotherapy.
The standard of care for metastatic TNBC (mTNBC) patients is chemotherapy, with taxane-based chemotherapeutic regimens considered first-line therapy. However, mTNBC patients have a poor prognosis even with this treatment. The median overall survival is approximately 18 months, or less, therefore, more effective treatment options for mTNBC are needed.
Magrolimab is not currently approved and is being studied in multiple types of cancers. It acts to help prevent cancer cells evading the immune system’s response and leads to the elimination of cancer cells from solid tumours. Magrolimab’s efficacy is best enhanced in combination with other anti-cancer agents.This study is split into two parts; the initial phase (safety run-in) to confirm a safe dose of magrolimab in combination with either nab-paclitaxel/ paclitaxel; and the second part (phase 2) to see if magrolimab in combination with nab-paclitaxel/ paclitaxel is effective in treating mTNBC.
The study will involve approximately 110 participants across 50 locations worldwide. Participants will be placed into one of the 2 cohorts (safety run-in or phase 2). The Phase 2 cohort will be divided into 2 groups; Arm A (magrolimab with nab-paclitaxel/paclitaxel) and Arm B (nab-paclitaxel/paclitaxel only). Participants will be randomly allocated into one of these treatment groups.
Treatment will be given in 28-day cycles and during the study participants will undergo multiple types of assessments, e.g. blood tests, CT/MRI scans, tumour biopsies, etc.
Summary of results:
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.gileadclinicaltrials.com%252Fstudy%253Fnctid%253DNCT04958785%2526lat%253D0%2526lng%253D0%2526distance%253D100%2FNBTI%2Fk-u_AQ%2FAQ%2F7c37bad2-33d7-43be-afc4-41ccaa06ee20%2F1%2FJ33Gq4glBu&data=05%7C02%7Charrow.rec%40hra.nhs.uk%7Ca07ed2c0ed2146f2320608ddcdf26592%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638893163147827167%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=m%2FPEegJEUgyKTJO%2BMWrC94y7DKUHBV1UdYrFzzFbH%2B8%3D&reserved=0
REC name
London - Harrow Research Ethics Committee
REC reference
22/LO/0112
Date of REC Opinion
21 Mar 2022
REC opinion
Further Information Favourable Opinion